The following data is part of a premarket notification filed by Imalux Corporation with the FDA for Imalux Oct Probe Guide.
| Device ID | K041077 |
| 510k Number | K041077 |
| Device Name: | IMALUX OCT PROBE GUIDE |
| Classification | Drape, Surgical |
| Applicant | IMALUX CORPORATION 1771 EAST 30TH STREET Cleveland, OH 44114 |
| Contact | Stephanie A.s. Harrington |
| Correspondent | Stephanie A.s. Harrington IMALUX CORPORATION 1771 EAST 30TH STREET Cleveland, OH 44114 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-06-25 |
| Summary: | summary |